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On 07-feb-2022, bridges consumer healthcare received a spontaneous report from (b)(4).(b)(4).On 26-jan-2022, (b)(4).Received a report from a pharmacist.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from (b)(6) received on 26-jan-2022 and additional information on 31-jan-2022 from a pharmacist through diamed ((b)(4)).This case report concerns a female patient (age not reported), who applied thermacare heat wraps for the neck (batch number ea5724 expiry date: 2023-05) for unknown indication.Concomitant medications and medical history were not reported.On an unknown date, after thermacare heat wraps initiation, the patient experienced local swelling, swelling of face and had to receive hospital treatment.The patient was treated with corticosteroids and antiallergic medications.The reaction at the location of the heat wraps was visible for several days.The patient had previous experience with thermacare for neck and hip and had never experienced any problems before.Outcome: unknown.The action taken in response to the events for thermacare heat wraps was unknown.
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On 07-feb-2022, bridges consumer healthcare received a spontaneous report from (b)(4).(b)(4).On 26-jan-2022, (b)(4).Received a report from a pharmacist.On 08-feb-2022, (b)(4).Provided additional information.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from (b)(6) received on 26-jan-2022 and additional information on 31-jan-2022 from a pharmacist through diamed ((b)(4)).This case report concerns a female patient (age not reported), who applied thermacare heat wraps for the neck (batch number ea5724 expiry date: 2023-05) for unknown indication.Concomitant medications and medical history were not reported.On an unknown date, after thermacare heat wraps initiation, the patient experienced local swelling, swelling of face and had to receive hospital treatment.The patient was treated with corticosteroids and antiallergic medications.The reaction at the location of the heat wraps was visible for several days.The patient had previous experience with thermacare for neck and hip and had never experienced any problems before.Outcome: unknown.The action taken in response to the events for thermacare heat wraps was unknown.Follow-up received on 08-feb-2022 from qa department.Complaint number (b)(4).Batch #: ea5724 product count: 2 count brand code/sku#: f00573300723w date of manufacture: 12-jun-2020 through 17-jun-2020 expiry date: 2023-may-31 quantity released: (b)(4) batch ea5724 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.Per (b)(4), consumer return samples and retain evaluations, effective 23-oct-2021, section 8.2: inspection of retain samples.The visual evaluation of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.(b)(4) retain sample inspection form was used to document the retain evaluation on 04-jan-2022 for a previous unrelated complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class md incident received at the (b)(6) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.The material records for (b)(4) skin contact adhesive laminate (sca); material number (b)(4) were reviewed.There was two batches of sca used in the manufacturing of the batch, batches 2001266064 and 2001266065.There were no raw material incident forms completed for the batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch that would cause an adverse event.Based on the information provided, the events local swelling and swelling of face as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The pi of thermacare neck shoulder wrist 12hr mentions that local swelling could be an adverse event of this medical device, whereas it does not mention swelling of face as adverse event.Dechallenge and rechallenge were not applicable.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare neck shoulder wrist 12hr and the incident is considered as possible.Batch ea5724 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.This device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.An evaluation of the complaint history confirms that this is the first complaint for the sub class md incident received at the (b)(6) requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.The material records for nsw/mj skin contact adhesive laminate (sca) were reviewed.There were no raw material incident forms completed for the batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.The batch has been reviewed from a manufacturing perspective.There were no investigations associated with this batch that would cause an adverse event.
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